Fetal Manual Rotation Clinical Trial
— RMOSOfficial title:
RMOS Study : Impact of Manual Rotation of Occiput Posterior Position on Operative Delivery Rate
Introduction:
The frequency of fetuses in occiput posterior position during labor is approximately 20 %,
in which 5% remain occiput posterior at the end of labor. Occiput posterior position is
associated with higher risks of caesarean deliveries and operative vaginal deliveries. The
manual rotation to promote rotation from a posterior to an anterior position has been
proposed to reduce the extraction rate. There is no randomised trial comparing the effect of
manual rotation and expectant management. We propose a protocol for a prospective,
monocentric, randomised controlled clinical trial in order to show that the rate of
spontaneous vaginal delivery is higher with manual rotation of occiput posterior position
than with an expectative management.
Methods:
Every 37 weeks with a singleton pregnancy with a clinical occiput posterior position
suspicion confirmed by a transabdominal ultrasound at full dilatation will be eligible.
Participants will be randomised to either prophylactic manual rotation (experimental group)
or expectative management (control group). Based on an alpha value of 0.05 and gaining 20%
for spontaneous vaginal delivery, 238 participants will need to be enrolled.
The primary outcome will be spontaneous vaginal delivery. Secondary outcomes will be
operative delivery rate (caesarean section , vacuum or forceps deliveries), significant
maternal and perinatal mortality/morbidity.
Analysis will be by intention-to-treat averaging a 24-month period.
| Status | Not yet recruiting |
| Enrollment | 238 |
| Est. completion date | |
| Est. primary completion date | January 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
1. Inclusion Criteria: - age = 18 years - singleton pregnancy -=37 weeks of gestation - planned vaginal birth - cephalic presentation - occiput posterior position confirmed by ultrasound at full dilatation 2. Exclusion Criteria: - withdrawal of consent |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Angers |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of spontaneous vaginal delivery | At the time of delivery | Yes |